| Device Type ID | 5712 |
| Device Name | Retention Device, Suture |
| Regulation Description | Suture Retention Device. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4930 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KGS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5712 |
| Device | Retention Device, Suture |
| Product Code | KGS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Suture Retention Device. |
| CFR Regulation Number | 878.4930 [🔎] |
| Device Problems | |
|---|---|
Break | 2 |
Torn Material | 1 |
Connector | 1 |
Positioning Failure | 1 |
Fracture | 1 |
Difficult To Remove | 1 |
Cuff | 1 |
| Total Device Problems | 8 |